Safety Needle Device

ABSTRACT

A safety needle device is disclosed having a housing configured to couple to a syringe, the housing having a proximal end, a distal end, and a housing body. A needle hub is disposed on the proximal end of the housing and a needle cannula is attached to the needle hub. The device having a retractable sheath configured to move between an initial position, a retracted position and an extended position with respect to the housing, wherein the initial position partially exposes a distal tip of the needle cannula, the retracted position fully exposes the needle cannula, and the extended position fully covers the distal tip of the needle cannula. The safety needle device may include an activation latch, a lockout latch, a tether and a spring element to bias the retractable sheath to an extended state to cover the distal end of the needle cannula upon completion of an injection. The safety needle device may include a slider element disposed above an activation latch. A method of drug delivery is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/837,011, filed on Dec. 11, 2017, which claims priority under 35U.S.C. § 119(e) to U.S. Provisional Application No. 62/433,350, filedDec. 13, 2016, the disclosures of which are incorporated herein byreference in their entirety.

TECHNICAL FIELD

The present disclosure relates generally to a safety needle device, andspecific embodiments pertain to a single-use passive safety needledevice having a housing, a needle hub, a needle cannula, a retractablesheath, an activation latch, a lockout latch, a tether and a spring tobias the retractable sheath in a distal direction to cover the distalend of the needle cannula.

BACKGROUND

Needle devices are used throughout the medical industry for theinjection and withdrawal of a wide variety of fluids and solutions intoand from the human body. Because of the numerous potential hazardsassociated with the handling and manipulation of bodily fluids, andparticularly blood, there are a number of known safety features that arefrequently incorporated into various types of needle devices to protectthe practitioner from accidental exposure to the needle.

Prior safety needle devices include several disadvantages includinghaving a retractable sheath requiring long stroke distances to activatethe safety feature, multi-component retraction and locking elements, andconveying an undesirable significant force against a patient's skinduring activation of the safety feature upon receiving an injection.Conventional retraction syringe assemblies often also do not incorporatereuse prevention features, and thus, the retraction mechanism of thesyringe may be reset so the syringe barrel may be reused. The reuse ofsyringe assemblies without sterilization or sufficient sterilization isbelieved to facilitate the transfer of contagious diseases. Further, theretraction features of conventional syringes may also require thepractitioner to actively activate the retraction mechanism. Accordingly,the chance of human error in failure to activate or properly activatethe retraction mechanism can lead to continued exposure of needlesleading to needle stick injuries.

Some known retracting sheath safety needle devices have been developedto include a single-use safety needle device assembly that obscures asubstantial majority or an entirety of an injection needle from viewbefore, during, and after an injection procedure. However, manyinjection procedures require that the practitioner know precisely thelocation and depth to which the needle is inserted in the patient'stissue to be sure that medication is delivered to an appropriatelocation. In addition, there exists a tendency for many practitioners tofalsely assume that they were “safe” from needle stick injuries, even inthe non-locked initial state, due to the tip of the prior art retractingsheath safety needle devices being fully covered in an unlocked state.

Thus, there is a need in the art to provide a safety needle devicehaving a passive activation mechanism that overcomes the deficiencies ofthe known retracting sheath safety needle devices and which allows forshorter stroke distance, ease of use, low part count, low partcomplexity, relatively compact design, and clear and unobstructed viewof needle in an initial position.

SUMMARY

One aspect of the present disclosure pertains to a safety needle deviceincluding a housing configured to couple to a syringe. The housingincludes a proximal end, a distal end, and a housing body. A needle hubmay be disposed on the proximal end of the housing and a needle cannulamay be attached to the needle hub. An activation latch may be disposedon an outer surface of the housing body and a retractable sheath may bedisposed on an inner surface of the housing body. The retractable sheathmay include a proximal end and a distal end. A retention shelf may bedisposed on the proximal end of the retractable sheath. A lockout latchmay be disposed on the retractable sheath to cover a distal tip of theneedle cannula. The retention shelf is releasably engaged to theactivation latch in an initial position, wherein the initial positionpartially exposes the distal tip of the needle cannula. A spring elementis disposed in the housing body and attached to the distal end of theretractable sheath. In one or more embodiments, the safety needle deviceis a single use device. In one or more embodiments, the safety needledevice is a passively activated device in which the safety featuresprovide post-injection needle shielding without additional interventionby the user.

In one or more embodiments, the safety needle device may include atether. In one or more embodiments, the tether may be a telescopingtether. In one or more embodiments, the telescoping tether includes afirst end attached to the housing body and a second end attached to theretractable sheath. In yet another embodiment, the telescoping tetherincludes a plurality of substantially concentric shells. The tether mayextend to form an enclosure around the cannula as retractable sheath ismoved distally along the length of the cannula.

In one or more embodiments, movement of the retractable sheath from theinitial position to a retracted position disengages the activation latchof the housing from the retention shelf on the proximal end of theretractable sheath.

In one or more embodiments, the lockout latch may be a metal latch.

In one or more embodiments, movement of the retractable sheath from theretracted position to an extended position engages the lockout latch toa distal tip of the needle cannula. The engagement of the lockout latchto the distal tip of the needle cannula inhibits reuse of the device byinhibiting translation of the retractable sheath. The spring elementbiases the retractable sheath toward the extended position.

In one or more embodiments, the retractable sheath translates from theinitial position to the retracted position upon an active depression ofthe activation latch.

In one or more embodiments, the needle cannula is obscured from viewwhen the retractable sheath is in the extended position.

In one or more embodiments, the spring element may be a coil spring.

Another aspect of the present disclosure pertains to a safety needledevice, including a housing configured to couple to a syringe, thehousing having a proximal end, a distal end, and a housing body. Aneedle hub may be disposed on the proximal end of the housing and aneedle cannula may be attached to the needle hub. An activation latchmay be disposed on an outer surface of the housing body and a sliderelement may be positioned in a longitudinal slot disposed over theactivation latch. The longitudinal slot may include a forward slot endand a rear slot end. A retractable sheath may be disposed on an innersurface of the housing body, the retractable sheath having a proximalend and a distal end. A retention shelf may be disposed on the proximalend of the retractable sheath. A lockout latch may be disposed onretractable sheath to cover a distal tip of the needle cannula. Theretention shelf releasably may be engaged to the activation latch in aninitial position, wherein the initial position partially exposes thedistal tip of the needle cannula; and a spring element disposed in thehousing body and attached to the distal end of the retractable sheath.

In one or more embodiments, the slider element includes a contactsurface having a profile for accommodating a practitioner's finger.

In one or more embodiments, the slider element may be in an initialprotective position in which the slider element is at the forward slotend of longitudinal slot and extends over the distal end of theactivation latch.

In one or more embodiments, the slider element may be in anon-protective position in which the slider element is at the rear endslot and extends over the proximal end of the activation latch allowingthe activation latch to release from the retention shelf of theretractable sheath.

Another aspect of the present disclosure pertains to a method of drugdelivery including obtaining the safety needle device described hereinin a safe state in which a distal tip of a needle cannula is covered;requiring a practitioner to makes a first choice whether to a) fill thesafety needle device with a desired liquid solution or b) Inject apatient; requiring a practitioner to makes a second choice based on thefirst choice to fill the safety device; and requiring a practitioner tomakes a third choice based on the second choice.

In one or more embodiments, the second choice may be whether to: a) fillthe safety needle device again, b) move the product to an inject state,or c) move the product to a transport state.

In one or more embodiments, after moving the product to the transportstate, the safety device needle is moved to into a safe state. In one ormore embodiments, the safe state includes placing a cap on the safetydevice needle.

Another aspect of the present disclosure pertains to a method of drugdelivery including obtaining the safety needle device described hereinin a safe state having a needle covered with a cap and a slider elementpositioned to prevent an activation latch from disengaging from aretention shelf of a retractable sheath; requiring a practitioner tomakes a first choice whether to (a) fill the safety needle device byremoving the cap and sliding the slider element over the activationlatch to prevent activation latch from disengaging from the retentionshelf of the retractable sheath while filling the device or (b) injectby removing the cap and insert the needle into a patient to delivermedication; requiring a practitioner to makes a second choice based onthe first choice to fill the safety device; and requiring a practitionerto makes a third choice based on the second choice.

In one or more embodiments, the second choice may be whether to: a) fillthe safety device needle repeatedly over a desired number of times, b)move the product to an inject state by sliding the slider mechanism offof the activation latch to allow for the release of the activation latchfrom the retention shelf on the retractable sheath during inject stateto allow for retractable sheath with its protective clip to cover thedistal tip of the needle cannula, or c) move the product to a transportstate by re-capping the safety needle device with a cap.

In one or more embodiments, the third choice may be whether to activelychange the state of product by removing the cap and moving the sliderelement to allow release of the activation latch from the retentionshelf on the retractable sheath to the inject state.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exploded view of a safety needle device accordingto a first embodiment;

FIG. 2 illustrates a perspective view of a safety needle device shown inFIG. 1 in an initial state;

FIG. 3 illustrates a sectional view of a first locking element of thesafety needle device shown in FIG. 1;

FIG. 4 illustrates another a sectional view of a first locking elementof the safety needle device shown in FIG. 1;

FIG. 5 illustrates a cross-sectional view of a safety needle deviceaccording to a first embodiment;

FIG. 6 illustrates another cross-sectional view of a safety needledevice according to a first embodiment;

FIG. 7 illustrates a perspective view of a safety needle device shown inFIG. 1 in a retracted state;

FIG. 8 illustrates a perspective view of a safety needle device shown inFIG. 1 in an extended state; and

FIG. 9 illustrates a perspective view of a safety needle deviceaccording to a first embodiment.

FIG. 10 illustrates a perspective view of a safety needle deviceaccording to a first embodiment.

FIG. 11 illustrates a perspective view of a safety needle deviceaccording to a first embodiment.

FIG. 12 illustrates a perspective view of a safety needle deviceaccording to a first embodiment.

FIGS. 13A and 13B illustrate a perspective view of a safety needledevice according to a first embodiment.

FIGS. 14A and 14B illustrate a perspective view of a safety needledevice according to a first embodiment.

FIGS. 15A and 15B illustrate a perspective view of a safety needledevice according to a first embodiment.

FIG. 16 illustrates a perspective view of a safety needle deviceaccording to a first embodiment.

FIG. 17 illustrates a perspective view of a safety needle deviceaccording to a first embodiment.

FIG. 18 illustrates a perspective view of a safety needle deviceaccording to a first embodiment.

FIG. 19 illustrates a perspective view of a safety needle deviceaccording to a first embodiment.

FIG. 20 illustrates a flow diagram for 3 Choice Passive Safety DeviceFunctional Architecture.

FIG. 21 illustrates a flow diagram for 3 Choice Passive Safety DeviceFunctional Architecture with Slider Cap device.

FIG. 22 illustrates a schematic for 3 Choice Passive Safety DeviceFunctional Architecture with Slider Cap device.

DETAILED DESCRIPTION

Before describing several exemplary embodiments of the presentdisclosure, it is to be understood that the embodiments of the presentdisclosure are not limited to the details of construction or processsteps set forth in the following description. The embodiments of thepresent disclosure are capable of other embodiments and of beingpracticed or being carried out in various ways.

With respect to terms used in this disclosure, the following definitionsare provided.

As used herein, the use of “a,” “an,” and “the” includes the singularand plural.

In this disclosure, a convention is followed wherein the distal end ofthe device is the end closest to a patient and the proximal end of thedevice is the end away from the patient and closest to a practitioner.

As used herein, a “safety needle device” refers to a device having aneedle suitable for injection that includes one or more features toprevent needle stick injuries. As used herein, a “passive safety needle”refers to a safety needle device with a passive activation mechanismthat automatically covers the distal end of the needle after a patienthas been injected.

Reference to “syringe” includes syringes that are indicated for use withneedles, nozzle, tubing, or for use in flush systems. As used herein,the term “syringe” refers to a simple pump-like device consisting of aplunger rod that fits tightly in a barrel or tube. The plunger rod canbe pulled or pushed along inside the barrel, allowing the syringe totake in and expel a liquid or gas through an opening at the open end ofthe barrel. The open end of the syringe may be fitted with a needle,nozzle, or tubing to help direct the flow of fluid into and out of thebarrel. The syringe may be sterile or unsterile, depending upon theneeds of the technician.

Embodiments of the safety needle device of the present disclosureprovides a passive activation mechanism that overcomes the deficienciesof the known retracting sheath safety needle devices by allowing for ashorter stroke distance, ease of use, increased patient comfort, lowpart count, low part complexity, relatively compact design, and clearand unobstructed view of needle in an initial position.

FIGS. 1-6 illustrate an exemplary safety needle device 10 according tothe present embodiments of the present disclosure. Safety needle device10 includes a housing 20 configured to couple to a syringe (not shown).Housing 20 having a proximal end 21, a distal end 22, a housing body 23and an opening 24 located on the distal end. Tether 30 is disposed onthe housing body 23. Tether 30 is generally parallel to a central axiswhich extends along the housing body 23.

Housing 20 may be of a unitary construction or may be formed from aplurality of components. In one or more embodiments, a proximal end 21and a distal end 22 of the housing 20 can be separate components thatare joined using techniques, such as but not limited to sonic welding,adhesive, snap or press fitting, or the like.

Needle hub 40 is disposed on the proximal end 21 of the housing 20.Needle cannula 42 is attached to the needle hub 40. In one or moreembodiments, the proximal end 21 of the housing 20 may be connectable toa luer connection or other fluid connector. As shown in FIG. 1, distalend 22 of housing 20 couples to a retractable sheath 50 such that theretractable sheath 50 is configured to move along a central axis inhousing body 23. A channel and an aperture are included in theretractable sheath 50 in order to permit the needle cannula 42 anddistal tip 44 of needle cannula 42 to pass therethrough.

Retractable sheath 50 is slidably mounted and movable in the opening 24of the housing body to slidably accommodate and encase needle cannula 42projecting axially from housing 20. The proximal end of retractablesheath 50 includes a stop or retention shelf 52 configured to allow theretractable sheath to move between an initial position, a retractedposition and an extended position with respect to the housing 20,wherein the initial position partially exposes a distal tip 44 of theneedle cannula 42, the retracted position fully exposes the needlecannula 42, and the extended position fully covers the distal tip 44 ofthe needle cannula 42. In one or more embodiments, the retention shelf52 may be in the shape of a hook. The term “retractable sheath” isintended to include any sort of tubular member and U-shaped member. Theretractable sheath 50 is dimensioned to be compatible with the size andtype of needle cannula 40 as will be appreciated by those skilled in theart. The housing 20 includes a housing body 23 with an internal hollowregion in which the retractable sheath 50 may move in the proximal anddistal direction.

FIG. 1 illustrates a safety needle device 10 that may be removablycoupled to a standard or specially configured syringe (not shown).Although the illustrated safety needle device 10 is configured to becoupled to and removed from a syringe, the safety needle device 10 mayinstead be integrally formed with the syringe. The syringe is generallyof a known type suitable for the withdrawal and injection and/oraspiration of fluids or other solutions by way of the safety needledevice 10.

Referring now to FIG. 1-2, the safety needle device 10 is illustrated inan initial state wherein the retractable sheath 50 is in a partiallyretracted configuration. Further retraction of the retractable sheath 50is generally initiated by a practitioner applying pressure on the safetyneedle device 10 and/or syringe in the distal direction, which therebyencourages the retractable sheath 50 proximally against the bias of thespring element 80. This retraction of the retractable sheath 50 in turnfurther exposes the distal tip 44 of the needle cannula 42 and initiatespenetration by the needle cannula 42 into the patient's skin.

As shown in FIG. 1, needle cannula 42 may be connected to a needle hub40 disposed at the proximal end 21 of the housing 20 and having ablunted tip (not shown) or beveled tip (as shown in FIG. 1) at thedistal tip 44 of needle cannula 42. The needle cannula 42 is disposed inthe needle hub 40 in a manner as would be well understood in the art.The needle hub 40 may be integrally formed with the proximal end 21 ofhousing 20. Needle hub 40 may be configured to be removable orpermanently attached to the syringe, or alternatively, needle hub 40 maybe integrally formed with the syringe. For example, needle hub 40 mayinclude internal or external threads or other suitable coupling,latching, or locking features such as tabs, slots, projections,pressure/snap fits, and the like, for removably coupling the safetydevice to a syringe. In some embodiments, the housing 20 includes agenerally cylindrically reduced needle support 41 that extends axiallyfrom the needle hub 40 to support the needle cannula 42. Housing 20and/or needle hub 40 are in fluid communication with the needle cannula42 to permitting fluid to pass between the syringe and the needlecannula 42.

The needle cannula 42 extends from the needle hub 40 disposed in thehousing 20 and extends to a distal tip 44. In an initial state, as shownin FIGS. 1-3, the distal tip 44 of the needle cannula 42 is partiallyexposed and protruding from the distal end of the retractable sheath 50so as to be visible when the retractable sheath 50 is in an initialposition, as shown in FIGS. 1-3. The shaft of the needle cannula 42 isincreasingly fully exposed from the retractable sheath 50 when theretractable sheath 50 is in a retracted position.

As illustrated in several of the drawings, most notably FIGS. 1 and 2,retractable sheath 50 is generally comprised of a tubular portion and isslidably retractable along the length of the needle cannula 42 such thata distal tip 44 of the needle cannula 42 is partially exposed andprotruding from the distal end of the retractable sheath 50 when in aninitial position so as to be visible to a practitioner. A substantial orentire portion of needle cannula 42 is exposed when the retractablesheath 50 is in its retracted position. The length of needle cannula 42which extends from the needle hub 40 in a distal direction is completelyencased when retractable sheath 50 is in its extended position, as shownin FIG. 6.

The needle cannula 42 in accordance with the present disclosure can beformed from conventional materials such as steel or more preferablystainless steel. It will be realized by the skilled artisan that medicalgrade plastics, composites, ceramics, or like materials can besubstituted.

The inside diameter of the retracting sheath 50 is selected so that itwill fit closely over needle cannula 42. The retracting sheath 50 may bemade of any suitable material, but preferably of a polymer which istough enough to protect needle cannula 42.

The proximal end 51 of retractable sheath 50 includes a retention shelf52 that extends radially outward from the proximal end of retractablesheath 50 and is configured to engage the activation latch 60 of thehousing body 23. As shown in FIGS. 1 and 2, housing 20 has an openingthat receives the retractable sheath 50.

In one or more embodiments, retractable sheath 50 may be disposed andmovable in the housing body 23. The retractable sheath 50 is springloaded, and is supplied to the practitioner with the retracting sheath50 partially covering the needle cannula 42 so that the distal tip ofthe needle cannula is exposed and visible in an initial state, as shownin FIG. 2. Upon administration of the injection, the retractable sheath50 moves from an initial position whereby the distal tip 44 of theneedle cannula 42 is exposed to a retracted position whereby the needlecannula is increasingly exposed so that the needle cannula may penetratethe injection site.

One aspect of the present disclosure pertains to a safety needle devicethat allows for either “Inject Only” or “Integrated Fill and Inject”procedures for fluids, including fluids and solutions used in medicalprocedures. As shown in FIGS. 1 and 2, one or more embodiments of thesafety needle device 10 include an activation latch 60 in combinationwith a spring element 80. As shown in FIGS. 3-6, in the initial stateboth the activation latch 60 and the spring element 80 hold storedenergy. Upon beginning injection, the energy in the activation latch 60is released once the retention shelf 52 on the proximal end of theretractable sheath 50 is released from engagement with the activationlatch 60 upon a practitioner depressing the activation latch over a veryshort distance.

Once the activation latch 60 is released from the retention shelf 52 onthe proximal end of the retractable sheath 50, the practitioner cancontinue to inject the cannula to their desired depth in a patient orvial by either utilizing the full length of the needle or asignificantly shorter distance of the needle cannula. Upon removing theneedle cannula 42 from a patient, the retractable sheath 50automatically advances forward and the stored energy in the springelement 80 is released allowing retractable sheath 50 to continues to bepushed forward until the lockout latch 70 is able to clip over thedistal tip 44 of the needle cannula 42 thereby passively locking out thesafety needle device 10 and preventing needle stick injury to thepractitioner. In one or more embodiments, activation latch 60 may be ametal latch. In one or more embodiments, lockout latch 70 may be a metallatch.

As shown in FIGS. 3-6, in one or more embodiments, safety needle device10 may operate in an “Inject Only” state, wherein the safety needledevice 10 passively locks out after one compression of retractablesheath 50 upon release of the activation latch 60 from retention shelf52.

During administration of an injection to a patient, the application offorce on the needle device by the practitioner in the distal directionand/or depression of the activation latch 60 by the practitioner causesthe retractable sheath 50 to move in a proximal direction. In or moreembodiments, the retractable sheath translates from the initial positionto the retracted position without impediment. A continued application offorce by the practitioner in the distal direction causes activationlatch 60 to disengage from the retention shelf 52 thus activating thelockout latch 70. In one or more embodiments, the lockout latch 70includes a metal latch on a distal end of the retractable sheath.Movement of the retractable sheath from the initial position to theretracted position disengages the activation latch 60 from the retentionshelf 52. In some embodiments, the activation latch 60 is generallyresilient, so that the radially inwardly disposed second ends can flexand then return to the original position even after the ends have beenradially outwardly deflected. In one or more embodiments, the activationlatch 60 may include a latching member, such as a shelf, clasp, detent,ratchet, or other structure.

Upon completion of an injection to the patient, the practitionerwithdraws the needle cannula from the patient, thus causing the storedenergy of spring element 80 to allow the retractable sheath 50 toproceed to fully covers needle cannula 42 in the extended position. Thespring element 80 biases the retractable sheath 50 in a distal directionto cover the distal tip 44 of needle cannula 42 causing activation ofthe lockout latch 70 to prevent further translational movement of theretractable sheath 50 within the housing body 23. Movement of theretractable sheath from the retracted position to the extended positionengages the lockout latch 70 to a distal tip of the needle cannula.

In one or more embodiments, the lockout latch 70 is disposed on theretractable sheath and rides along the needle cannula until the lockoutlatch 70 covers the distal tip 44 of the needle cannula 42 in theextended position. In one or more embodiments, the retractable sheath 50extends in length beyond the lockout latch 70, as seen in FIG. 1. In oneor more embodiments, lockout latch 70 comprises a protective clip whichcan cover the distal tip 44 of the needle cannula 42 in the extendedposition. In one or more embodiments, the lockout latch 70 inhibitsreuse of the safety needle device 10 by inhibiting further translationalmovement of the retractable sheath 50 within the housing body 23 bycovering the distal tip 44 of the needle cannula 42 in the extendedposition. Needle cannula 42 is obscured from view when the retractablesheath is in the extended position. As shown in FIG. 6, as the injectionis completed and the distal tip 44 of needle cannula 42 is pulled frominjection site, the stored force of spring element 80 causes theretracting sheath 50 to extend, and at the end of the stroke, a lockoutlatch extends over the distal tip of the needle cannula 42 to lock theretractable sheath 50 thereby completing a passive safety lock-out. Inone embodiment, the lockout latch is a metal clip.

Spring element 80 includes a proximal end, a main body, and a distalend. In one or more embodiments, as shown in FIG. 1, spring element 80comprises a compression or coil spring. The spring element 80 biases theretractable sheath toward the extended position.

In one or more embodiment, spring element 80 engages and extends betweenthe proximal end of the retractable sheath and the proximal end of thehousing. The spring biases the retractable sheath 50 toward an initialposition in which the retention shelf 52 of the retractable sheath 50 isbiased into engagement with the activation latch located at the distalend of the housing body 23 thereby allowing the distal tip 44 of theneedle cannula 42 to be exposed and visible in the initial position. Theretractable sheath 50 completely covers the distal tip 44 of the needlecannula 42 in the extended position. Many types of springs may beemployed, such as but not limited to a helical coil spring, conicalspring, wave-spring, or the like. In some embodiments, the springelement 80 is configured to facilitate retraction of the retractablesheath 50 by a practitioner applying distal pressure to the syringeand/or the safety needle device 10 with just one hand.

Safety needle device 10, and components thereof, can be formed usingmany manufacturing processes sufficient to provide the desired shape ofthe components. In some embodiments one or more components are made by amolding process, such as but not limited to injection molding,compression molding, blow molding, transfer molding, or similar. In someembodiments, one or more components are formed by forging, machining,casting, stamping, extrusion, a combination thereof, or the like.

In many embodiments, the safety needle device 10 is constructed from abiocompatible material. In some arrangements one or more of thecomponents of the safety needle device 10 are plastic (e.g.polyurethane, etc.) or metal (e.g., stainless steel, etc.). In someembodiments, the housing 20 and/or the retractable sheath 50 areconstructed of materials that are either translucent or opaque.

In some embodiments, movement of the retractable sheath 50 to disengagethe retention shelf of the retractable sheath from activation latch 60will allow for automatically engagement of lockout latch 70 with thedistal tip 44 of needle cannula 42. In some embodiments, movement of theretractable sheath 50 from an about fully retracted position to an aboutfully extended position automatically prevents or inhibits reuse of thesafety needle device 10.

In embodiments in which housing 20 comprises multiple pieces, themanufacturing process can include the step of assembling the housing 20.A retractable sheath is formed having retention shelf 52 which isaligned for engagement with activation latch 60. The retractable sheath50 is slidingly moved through the opening 24. The needle cannula 42 iscoupled with the needle support 41 of the housing 20. The spring element80 is inserted into the housing body 23 and positioned to bias theretractable sheath 50.

As shown in FIG. 5, as the retractable sheath 50 continues to retractinto the housing body 23, to further expose the needle cannula 42. Uponwithdrawal of the needle cannula 42 from the patient, the stored springenergy of the spring element 80 to distally extend the retractablesheath 50. As the retractable sheath 50 distally extends, it covers theneedle cannula 42 into the channel of the hub body thereby covering thedistal end of the needle cannula 42. As shown in FIG. 6, upon reachingthe retractable sheath 50 reaching the distal tip 44 of the needlecannula 42, the lockout latch 70 moves distally over the distal tip tocover the distal tip 44 of the needle cannula 42 to prevent reuse of thesafety needle device 10. The retractable sheath 50 has been fullyextended and fully covers the needle cannula 42. The lockout latch 70thus presents a physical stop to inhibit the retractable sheath 50 frombeing proximally retracted again.

Another aspect of the present disclosure pertains to a safety needledevice having a telescoping tether having a first end secured to the hubor housing and a second end secured to the retractable sheath. In onemore embodiments, incorporation of a telescoping tether allows theoverall size of the safety needle device to be significantly reduced.FIGS. 1-12 and 19 show a perspective view of another embodiment having atether 30.

As shown in FIGS. 1-12 and 19, safety needle device 10 further comprisesa tether 30, which connects the housing 20 and is telescoping. As theretractable sheath 50 moves distally along the needle cannula 42, thetether 30 extends to the length of the needle cannula 42. The tether 30thus provides an extensible length beyond which the housing 20 may notdistally extend.

The tether 30, having a proximal end and a distal end, may have theproximal end affixed to housing 20 or hub 40 and the distal end of thetether may be affixed to the retractable sheath 50 by any suitablefastening mechanism including, but not limited to adhesives, pointwelding, rivets, and heat sealing. In one or more embodiments, tether 30may be in the form of a tube or concentric cone-shaped enclosures. Thetether 30 deploys in the form of a tube or cone-shaped enclosure aroundthe needle cannula 42. Tether 30 extends to form an enclosure around thecannula as retractable sheath is moved distally along the length of thecannula.

Other configurations for the tether 30 are possible. In one or moreembodiments, as shown in FIG. 19, tether 30 may comprise a plurality ofsubstantially concentric shells. In one or more embodiments, tether 30distally extends along the needle cannula 42, and the concentric shells(32, 34, and 36) of the tether 30 slide past each other to cover orcompletely envelope the needle cannula 42. In one or more embodiments,the tether extends to form a substantially cone-shaped enclosure aroundthe cannula as the retractable sheath is moved distally along the lengthof the cannula. In certain embodiments, the tether is a plurality ofsubstantially concentric shells which are axially telescoping andenvelope the cannula as the retractable sheath is moved distally alongthe length of the cannula.

As shown in FIG. 19, tether 30 may include a plurality of concentricshells 32, 34, 36. The outermost concentric shell 32 may be affixed tothe inner surface of the housing 20 or needle hub 40, and the innermostconcentric shell 36 may be affixed to the retractable sheath 50.Concentric shells 32, 34, 36 are designed to telescopically slide withrespect to each other, but not to extend past each other, and the totalextension length of the tether 30 is long enough to permit theretractable sheath 50 to cover the length of needle cannula and forlockout latch 70 to extend over and cover the distal tip 44 of theneedle cannula. Tether 30 is configured to fully cover needle cannula 42when the retractable sheath is maximally extended to cover and shieldthe distal tip 44 of the needle cannula.

Another aspect of the present disclosure pertains to housing 20 furtherincludes a slider element 100 that extends over activation latch 60extending radially from an external surface of housing 20.

As shown in FIGS. 7-12, safety needle device 10 is configured to enable“fill and inject” wherein activation latch 60 is held down when thesafety needle device 10 is in the fill state so that retention shelf 52on the proximal end of the retractable sheath 50 remains engaged to theactivation latch 60 after each fill. As shown in FIGS. 7-12, in one ormore embodiments, safety needle device 10 may include a slider element100 to hold down activation latch 60 to ensure that retention shelf 52on the proximal end of the retractable sheath 50 remains engaged to theactivation latch 60, thus preventing the stored energy in the activationlatch 60 from being released. In yet another embodiment, slider element100 may be configured to toggle in a perpendicular direction withrespect to the needle cannula.

Desirably, activation latch 60 is integrally formed with housing 20extending from an outer surface of hub body. Slider element 100 may alsoinclude a contact surface having a profile for accommodating apractitioner's finger. As shown in FIGS. 7-12, slider element 100 ispositioned in a longitudinal slot 110, with finger surface extendingbeyond longitudinal slot 64 at the outer surface of housing 20.

Safety needle device 10 is capable of assuming a position for protectionand a position for use by way of translating the slider element 100 froman initial protective position in which the slider element 100 is at theforward slot end of longitudinal slot and extends over the distal end ofthe activation latch to moving the slider element in an proximaldirection such that the slider element extends over the proximal end ofthe activation latch thus allowing the activation latch from releasingfrom the slot of the retractable sheath. To prevent retractable sheath50 from being released from the initial position, slider element 100 isat the forward slot end thus preventing activation latch 60 fromreleasing from retention shelf 52 of retractable sheath 50. Activationlatch 60 locks retractable sheath 50 through engagement with retentionshelf 52 disposed on the proximal end of retractable sheath 50 whenslider element 100 is located at the forward slot end of longitudinalslot, as shown in FIG. 10.

Once the use moves the slider element 100 at the rearward slot end thusallowing the release of activation latch 60 from the retractable sheath50 once the retractable sheath is moved in a proximal direction duringthe administration of an injection to a patient. Upon activation,activation latch 60 releases retractable sheath 50 when activation latch60 is no longer in an interference engagement with the retention shelf52 disposed on the proximal end of retractable sheath 50.

Movement of the activation latch from a forward slot end to the rearwardslot end disengages the enlarged portion of the protective clip frominterference engagement with retention shelf 52 of the retractablesheath. This releases retractable sheath from the locked position, thusallowing free movement of retractable sheath 50 within the housingtoward the distal tip 44 of needle cannula 42. In one or moreembodiments, this may be accomplished by exerting pressure on fingercontact surface of the activation latch 60.

Distal tip 44 of needle cannula 42 is completely covered by theprotective clip of the retractable sheath to prevent re-exposure thereofwithout any further action on the part of the practitioner.

Safety needle device 10 may include means for storing energy extendingbetween housing 20 and retractable sheath 50, such that upon release ofthe activation latch, retractable sheath 50 is automatically forcedforward along longitudinal axis thereby automatically enabling shieldingof needle cannula 42.

The means for storing energy may be a spring element 80, such as acompression spring. Spring element 80 may extend between the distal endof retractable sheath 50 and proximal end of housing 20.

The needle safety device of the present disclosure provides a simplemechanism for causing actuation of the shielding feature with a singlehand of the practitioner.

In yet another embodiment, as shown in FIGS. 13A-18, a blocking member120 may utilized in combination with a spring element to pivot thatblocking member 120 in order to achieve lockout and thereby preventingthe needle from re-finding the hole. In one or more embodiment, blockingmember 120 as housed inside the sheath as shown in FIGS. 13A, 13B, 14Aand 14B. In one or more embodiment, blocking member 120 may beconfigured as an integrated block that utilizes a living hinge as shownin FIGS. 15A and 15B. As shown in FIGS. 13A, 13B, 14A and 14B, a sheathmay be used that that utilizes the energy in a spring element to biasthe sheath upon lockout so that the needle and the hole are no longerco-axial preventing it from once again finding the hole. In one or moreembodiments, blocking member 120 may be configured as an angled plasticcomponent.

In one or more embodiments, as shown in FIGS. 13A-15B, blocking elementcomprises a block having a diagonal channel within the body of theblocking element attached to spring element is provided. In an initialstate, the cannula is threaded through the diagonal channel suchallowing the distal tip of the cannula to protrude from the distal endof the retractable sheath 50 such that distal tip of the cannula isvisible to the practitioner while the spring element exerts force onblocking element to maintain the blocking element in a biased state atthe distal end of the retractable sheath 50. Upon administration of aninjection to a patient, the retractable sheath 50 moves in a proximaldirection such that the needle cannula moves out of the diagonal channelallowing the blocking member to rotate to an unbiased state such thatthe cannula is prevented the distal tip 44 of needle cannula 42 fromre-entering the diagonal channel within the body of the blocking elementto prevent exposure of the practitioner from the distal tip 44 of needlecannula 42. It will be appreciated that the blocking element may bemounted to a spring element, or it may be an integral part of, thedistal end of the retractable sheath 50.

If the distal tip of the cannula attempts to pass back through thediagonal channel, the distal tip will be buttressed by the body of theblocking member thus causing the distal tip to remain safely disposedwithin the housing 20 and prevented by the tether 30 and blocking memberfrom exiting the confines of the housing 20.

When the needle cannula 42 is withdrawn from the patient, the patient'sskin no longer obstructs forward movement of the retractable sheath 50,and the retractable sheath 50 then moves to the extended position asshown in FIG. 14A. As shown in FIGS. 13A-15B, the retractable sheath 50has an opening through which the needle cannula 42 extends in an initialposition.

The misalignment of the needle cannula 42 with the diagonal channelprevents the needle cannula 42 from extending back out of the diagonalchannel after use. Furthermore, the blocking element may be made ofstrong material to prevent the distal tip 44 of the needle cannula 42from piercing through the blocking element.

In one or more embodiments, the safety needle device 10 can include acap that is removably coupled to the housing 20 to reduce or preventcontamination of the needle cannula during shipping and storage of thesafety needle device 10. The cap is generally kept in the closedposition until just prior to an injection and/or aspiration procedure,at which time the cap is removed from the housing 20.

It is also envisioned that in one or more embodiments of the presentdisclosure, safety needle device 10 does not included includes a tether30. In such an embodiment, housing 20 has a proximal end 21, a distalend 22, a housing body 23 and an opening 24 located on the distal end.Distal end 22 of housing 20 couples to a retractable sheath 50 such thatthe retractable sheath 50 is configured to move along a central axis inhousing body 23.

Any suitable caps or packaging comprising a safety feature may be usedin conjunction with the safety needle device disclosed herein. Anysuitable caps or packaging comprising a safety feature may be used inconjunction with the safety needle device disclosed herein. Types ofsafety features vary in structure and mechanics but exemplary caps orpackaging include, but are not limited to, those described in commonlyowned, U.S. Patent Application Ser. Nos., 62/433,044, 62/433,526 and62,433,297, the disclosures of which are incorporated herein byreference in their entireties.

Another aspect of the present disclosure pertains to a “3 Choice”Passive Safety Device Functional Architecture which allows apractitioner to both fill and inject with the same needle safety device.During this process the practitioner has the opportunity to make 3choices throughout the use of needle safety device. FIG. 20 illustratesa flow diagram for 3 Choice Passive Safety Device FunctionalArchitecture. FIG. 21 illustrates a flow diagram for 3 Choice PassiveSafety Device Functional Architecture with Slider Cap device. FIG. 22illustrates a schematic for 3 Choice Passive Safety Device FunctionalArchitecture with Slider Cap device.

As shown in FIG. 20, to start, a safety needle device comes packaged ina safe state in which the needle is covered and prevents needle stickinjury (NSI). This can be in the form of a hard-pack or in a blisterwith a separate cap. At this point the practitioner makes the firstchoice: whether to a) Fill (e.g. access a vial to fill a syringe ortransfer fluids) or b) Inject (insert the needle into a patient todeliver medication). In one or more embodiments, at the first choice,the practitioner may actively change the safety needle device to thatstate by either activating the activation latch or sliding the slidermechanism to release the activation latch from the retention shelf onthe retractable sheath as discussed above. Assuming the practitionerchooses to Fill, once they complete filling, they now make the secondchoice whether to: a) fill the safety needle device again (e.g. performanother vial access), b) move the product to an inject state, or c) movethe product to a transport state. In one or more embodiment, each ofthese choices requires an active motion by the practitioner. Assumingthe practitioner chooses to move the product to the transport state,they now place the safety device needle into a safe state that couldprevent NSI's (e.g. place a cap on the safety device needle). Followingtransportation, the practitioner then needs to make the third choice:whether to actively change the state of product (e.g. move the sliderelement to allow release of the activation latch from the retentionshelf on the retractable sheath) to the inject state. Once in the injectstate, within approximately the first 5 mm or less of the needlepenetrating the patient's skin (or other medium) the device willautomatically lock out by allowing the retractable sheath with itsprotective clip to cover the distal tip of the needle cannula—therebydefining passive safety. In one or more embodiments, “Fill”, “Inject”and “Trash” symbols will be depicted on the safety device needle suchthat the slider will point to each during that state.

As shown in FIG. 21 and FIG. 22, to start, a safety needle device comespackaged in a safe state in which the needle is covered with a cap,along with a slider element that may be positioned to prevent activationlatch from disengaging from the retention shelf of the retractablesheath, as discussed above, to prevent needle stick injury (NSI). Atthis point the practitioner makes the first choice: whether to a) Fill(e.g. access a vial to fill a syringe or transfer fluids) by removingthe cap and sliding the slider element over the activation latch toprevent activation latch from disengaging from the retention shelf ofthe retractable sheath while filling the device or b) Inject (e.g.removing the cap and insert the needle into a patient to delivermedication). In one or more embodiments, at the first choice, thepractitioner may actively change the safety needle device to either afill state (e.g. by sliding the slider element over the activation latchto prevent release of the activation latch from the retention shelf onthe retractable sheath while filling or actively changing the safetyneedle device) or to an inject state (e.g. by sliding the slidermechanism off of the activation latch to allow for the release of theactivation latch from the retention shelf on the retractable sheathduring inject state to allow for retractable sheath with its protectiveclip to cover the distal tip of the needle cannula—thereby definingpassive safety. Assuming the practitioner chooses to Fill, once theycomplete filling, they now make the second choice whether to: a) fillthe safety device needle repeatedly over a desired number of times (e.g.perform another vial access), b) move the product to an inject state bysliding the slider mechanism off of the activation latch to allow forthe release of the activation latch from the retention shelf on theretractable sheath during inject state to allow for retractable sheathwith its protective clip to cover the distal tip of the needle cannula,or c) move the product to a transport state by re-capping the safetyneedle device with a cap. In one or more embodiment, each of thesechoices requires an active motion by the practitioner. Assuming thepractitioner chooses to move the product to the transport state, theynow place the safety device needle into a safe state that could preventNSI's (e.g. place a cap on the safety device needle). Followingtransportation, the practitioner then needs to make the third choice:whether to actively change the state of product (e.g. removing the capand moving the slider element to allow release of the activation latchfrom the retention shelf on the retractable sheath) to the inject state.Once in the inject state, within approximately the first 5 mm or less ofthe needle penetrating the patient's skin (or other medium) the devicewill automatically lock out by allowing the retractable sheath with itsprotective clip to cover the distal tip of the needle cannula—therebydefining passive safety.

FIG. 22 shows the safety needle device in an initial state and transferstate (with cap positioned on the safety needle device); inject state(distal tip of the needle cannula partially exposed and visible to thepractitioner); fill state (needle cannula fully exposed); and trashstate (with the distal tip of the needle cannula fully covered by theretractable sheath and protective clip.

In one or more embodiments, symbols for “Fill”, “Inject”, and “Trash”may be depicted on the safety needle device. In one or more embodiments,slider element 100 will point to the appropriate symbol for “Fill”,“Inject”, or “Trash” to indicate the status of the safety needle device.In one or more embodiments, safety needle device comes packaged with acap in an Inject State with only the needle tip exposed. To inject,remove the cap and inject after which the safety needle devicepermanently locks out. To Fill, practitioner moves the slider elementfrom the “Inject” to “Fill” Symbol and fill an infinite number of timesduring which no force will be imparted on the vial. To Transfer thesafety needle device, the practitioner places the cap back onto thesafety needle device.

Whenever the safety needle device is in a “fill state” it is in a statethat allows for potential needle stick injury and when the needle entersinto a vial (or other medium) and then exits, it does not lock. Thismeans that a practitioner could access a vial to fill an infinite numberof times. Similarly, whenever the device is in an “inject state” it isin a state that also allows for potential needle stick injury. However,once the needle enters into a patient (or other medium) then then exitsit automatically locks after 1 time.

A practitioner can move the Inject State at any point in the process.This means that the practitioner can go from state to inject, fill toinject, or transport to inject as indicated above.

As shown in FIGS. 20-22, the needle safety device is delivered to thepractitioner in a safe state packaging in which the needle is coveredand thus prevents needle stick injury (NSI). Packaging can be in theform of a hard-pack or in a blister with a separate cap. At this pointthe practitioner makes the first choice: to either a) “Fill” byaccessing a vial to fill a syringe or transfer fluids, or b) Inject byinserting the needle into a patient to deliver medication—and theyactively change the device to that state. Assuming the practitionerchooses to Fill, once they complete filling, they now make a secondchoice: whether to a) fill again by performing another vial access; b)move the product to an inject state, or c) move the product to atransport state. Both the first choice and the second choice require anactive motion by the practitioner. If the practitioner chooses to movethe product to the transport state, the practitioner places the needlesafety device into a safe state that could prevent needle stick injury(NSI). Following transportation, the practitioner can subsequently makea third choice: whether to actively change the needle safety device toan inject state. Once the needle safety device is in the inject state,within approximately the first 5 mm or less of the needle penetratingthe patient's skin (or other medium) the needle safety device willautomatically lock out.

While the needle safety device is in a “fill state”, safety needledevice may allow for potential needle stick injury because as the needleof the needle safety device enters into a vial (or other medium) andthen exits, the needle safety device does not lock. This means that apractitioner could access a vial to fill an infinite number of times.

Similarly, whenever the safety needle device is in an “inject state” itis in a state that also allows for potential needle stick injury.However, once the needle enters into a patient (or other medium) thenthen exits it automatically locks after 1 time.

In one or more embodiments, the practitioner can move the needle safetydevice into the Inject State at any point in the process. Thus, thepractitioner can actively transition from inject to fill, fill toinject, or transport to inject.

In one embodiment, a needle safety device having a slider element alongwith a cap may be packaged to Inject. However, if the practitionerdecides to fill the safety needle device, the practitioner may proceedto fill after removing the cap from the needle safety device.Alternatively, if the practitioner decides to proceed directly to aninject state, the practitioner may proceed to inject after removing thecap from the needle safety device, whereby after the injection iscompleted the safety needle device would proceed to a permanent lock outstate. Similarly to fill prior to injection, the practitioner would needto move the axial slider from the Inject to Fill State, fill as manytimes as the practitioner desired, and then the practitioner wouldproceed to move the axial slider back to the inject state prior toinjection. In one or more embodiments, the slider would have a pointerand symbols and/or verbiage to help guide the practitioner. If transportof the needle safety device is desired between fill and inject, thepractitioner would need to recap the needle.

This passive safety activation will help to reduce the incident ofcontaminated needle stick injuries by ensuring that the deviceautomatically locks after injection when used as intended. Additionally,the needle safety device allows practitioners to fill and inject withinone product allowing for reduced materials, time savings, and areduction of cost to clinicians. Additionally, embodiments of thepresent disclosure allow for utilization of a greater distance of theneedle to fill allowing it to penetrate more stoppers that are on thecurrently available, as well as, providing a more “immediate” lock outwhen injecting a patient.

Reference throughout this specification to “one embodiment,” “certainembodiments,” “various embodiments,” “one or more embodiments” or “anembodiment” means that a particular feature, structure, material, orcharacteristic described in connection with the embodiment is includedin at least one embodiment of the disclosure. Thus, the appearances ofthe phrases such as “in one or more embodiments,” “in certainembodiments,” “in various embodiments,” “in one embodiment” or “in anembodiment” in various places throughout this specification are notnecessarily referring to the same embodiment of the disclosure.Furthermore, the particular features, structures, materials, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

Although the disclosure herein provided a description with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thedisclosure. It will be apparent to those skilled in the art that variousmodifications and variations can be made to the present disclosurewithout departing from the spirit and scope thereof. Thus, it isintended that the present disclosure include modifications andvariations that are within the scope of the appended claims and theirequivalents.

What is claimed is:
 1. A safety needle device, comprising: a housingconfigured to couple to a syringe, the housing having a proximal end, adistal end, and a housing body; a needle hub disposed on the proximalend of the housing; a needle cannula attached to the needle hub; anactivation latch disposed on an outer surface of the housing body; aslider element positioned in a longitudinal slot disposed over theactivation latch, the longitudinal slot having a forward slot end and arear slot end; a retractable sheath on an inner surface of the housingbody, the retractable sheath having a proximal end and a distal end, aretention shelf disposed on the proximal end of the retractable sheath;a lockout latch disposed on retractable sheath to cover a distal tip ofthe needle cannula; the retention shelf releasably engaged to theactivation latch in an initial position, wherein the initial positionpartially exposes the distal tip of the needle cannula; and a springelement disposed in the housing body and attached to the distal end ofthe retractable sheath.
 2. The safety needle device of claim 1, whereinthe activation latch is held down by the slider when the safety needledevice is in a fill state such that the retention shelf remains engagedto the activation latch after a fill.
 3. The safety needle device ofclaim 1, wherein the activation latch locks retractable sheath throughengagement with the retention shelf.
 4. The safety needle device ofclaim 1, the retractable sheath further comprising a protective cliphaving an enlarged portion.
 5. The safety needle device of claim 4,wherein movement of the activation latch from the forward slot end tothe rear lot end disengages the enlarged portion of the protective clipfrom interference engagement with retention shelf of the retractablesheath.
 6. The safety needle device of claim 1, wherein the activationlatch releases the retractable sheath when the activation latch is nolonger in an interference engagement with the retention shelf.
 7. Thesafety needle device of claim 1, wherein the slider element is in theinitial protective position in which the slider element is at theforward slot end of longitudinal slot and extends over the distal end ofthe activation latch.
 8. The safety needle device of claim 7, whereinthe slider element is in a non-protective position in which the sliderelement is at the rear end slot and extends over the proximal end of theactivation latch allowing the activation latch to release from theretention shelf of the retractable sheath.
 9. The safety needle deviceof claim 1, wherein the slider element includes a contact surface havinga profile for accommodating a practitioner's finger.
 10. The safetyneedle device of claim 1, wherein the slider element is configured totoggle in a perpendicular direction with respect to the needle cannula.11. A method of drug delivery comprising: obtaining a safety needledevice having a slider element positioned to prevent an activation latchfrom disengaging from a retention shelf of a retractable sheath in asafe state in which the safety needle device is covered with a cap;requiring a practitioner to makes a first choice whether to a) fill thesafety needle device by removing the cap and sliding the slider elementover the activation latch to prevent activation latch from disengagingfrom the retention shelf of the retractable sheath while filling thesafety needle device or b) Inject by removing the cap and insert theneedle into a patient to deliver medication; requiring a practitioner tomakes a second choice based on the first choice to fill the safetyneedle device; and requiring a practitioner to makes a third choicebased on the second choice.
 12. The method of claim 11, wherein thesecond choice is: a) fill the safety needle device repeatedly over adesired number of times, b) move the safety needle device to an injectstate by sliding the slider element off of the activation latch to allowfor a release of the activation latch from the retention shelf on theretractable sheath during an injection to allow the retractable sheathwith a lockout latch to cover a distal tip of a needle cannula, or c)move the safety needle device to a transport state by re-capping thesafety needle device with the cap.
 13. The method of claim 11, whereinthe third choice is whether to actively remove the cap and move theslider element to allow release of the activation latch from theretention shelf on the retractable sheath to an inject state.